Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse classification outcomes of inspections across biologics, drugs, and devices.
In 2023, the USFDA conducted 225 inspections, which led to 18 cases of Official Action Indicated (OAI) and 117 cases of Voluntary Action Indicated (VAI). By 2024, despite a tightening of regulatory standards, the number of inspections dropped to 206, while OAI cases fell to 14 and VAI cases reduced to 115. This highlights that the sector is increasingly aligning with global benchmarks to ensure high-quality manufacturing practices.
Looking back at the pre-pandemic years, there was a 100 percent increase in OAI status from 2018 to 2019. However, the onset of the pandemic in 2020 led to a 75 percent drop, and the status fell 50 percent in 2021.
This story is from the December 30, 2024 edition of Business Standard.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber ? Sign In
This story is from the December 30, 2024 edition of Business Standard.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 9,000+ magazines and newspapers.
Already a subscriber? Sign In
A global outreach beyond business
An ancient civilisation with a modern outlook, India has a lot of fine strengths – in cinema, sports, art, culture, food, yoga – that it is building on
Union Carbide waste disposal: Protests rock Pithampur, 2 attempt self-immolation
Two persons on Friday attempted self-immolation, adding to tensions in Pithampur, Madhya Pradesh, as protests against the planned disposal of 337 tonnes of hazardous waste from Bhopal's defunct Union Carbide factory continued in the small industrial town.
Over 500 flights delayed, 24 train ops hit in Delhi
Palam airport records zero visibility from 8 am to 9.30 am Friday
AFTER SINDHU, WHO?
Women's badminton faces uncertainty due to a shrinking talent pool, lack of quality coaches, and overreliance on Gopichand
No cause for alarm: Indian health officials on hMPV spread in China
As the world marks the fifth anniversary of the Covid-19 pandemic in 2025, another flu-like illness has emerged, though Indian officials insist there is no reason to panic.
Jefferies: '25 may be year of monetary easing in India
Brokerage raises target price for HDFC, ICICI Bank
Avenue Supermarts hits 15% upper circuit after Q3 update
Avenue Supermarts (owner of DMart retail chain) shares clocked 15 per cent upper circuit in trade on BSE at ₹4,160.4 per share on Friday. Buying in the stock sparked after the company released its Q3 business update.
Film producer Vipul Shah's Sunshine Pictures files DRHP
Film and television producer-director Vipul Shah-backed Sunshine Pictures has filed draft papers with the market regulator Sebi to raise funds through an initial public offering (IPO).
MFs' Equity Buying Topped ₹4 Trillion in 2024
Mutual funds' (MFs) equity buying jumped over twofold in 2024 to top ₹4 trillion for the first time.
Quadrant Future fixes price band at ₹275-290, offer opens on Jan 7
Quadrant Future Tek on Friday said it has fixed the price band at ₹275-290 per equity share for its ₹290-crore initial public offering (IPO) that will open for public subscription on January 7.
